Validation and compliance experience of this consultant covers coordination, leadership and project management, qualification (IOP/Q). This consultant has experience in coordinating the validation and installation activities with other consultants, engineering firms and construction contractors

Professional Experience

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in facilities, utilities, process, equipment/systems, and computer system validation (CSV), qualification/validations, manufacturing and packaging, and related expertise to a wide variety of clients.

Developed installation and operational qualification protocols (IOQ) for manufacturing equipment within the Fill and Finish plant including Computer System Validation (CSV). Developed Requirement and Design Specification documents for manufacturing equipment. Executed installation and operational protocols.

Developed critical utilities certification statement for DI water, HVAC, Nitrogen, Negative Exhaust, Central Vacuum and Solvent System as part of the actions agreed in the Consent Decree of permanent injunction. Gathered and evaluated utilities performance data. Assessed cGMP's compliance of supporting documents. Assessed systems control status. Issued relevant utilities control statements as required. Interacted with utilities owner for the resolution of noted deviations. Developed commissioning and IOQ report for the solvents system supporting the API Manufacturing Operations. Executed Process Validation Protocols, Development Studies, Primary and Secondary Packaging Validations and Special Packaging Testing. Provided support to technical services department for the product transfer and validation of the Afrin (aerosols) presentations. Also participated on Special Study conducted to identified and isolate problems on the primary packaging area. Provided summary reports preparation for the related protocols.

Let us quickly locate the best and most qualified expert or expertise you need.